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Spex

by Spex Ltd 188 variants

Ref 1102-1010-WSS

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number94200517WONDERSEATDT Basic UDI-DI 09420082695948UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09420082695948 UDI-DI Date1 Nov 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Spex EUDAMED
Spex Limited GUDID
Generic Name
Wheelchair seat cushion
Device Name
Spex Wonderseat
Model / Reference
1102-1010-WSS
Primary DI / UDI-DI
09420082695948
Basic UDI-DI
94200517WONDERSEATDT
Direct Marketing DI
09420082695948
FDA Product Code
IMP
EMDN Code
Y122406 Belts, seats and armrests for wheelchairs
GMDN Term
Wheelchair seat cushion
Device Class
Class I
Regulation Number
890.3920
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
NZ-MF-000009327
Authorised representative
BEO MedConsulting Berlin GmbH DE-AR-000006764

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See all devices from Spex Ltd →

Properties

  • Single Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No